Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife Recalled by Tecfen Medical Due to Sterility assurance for Ophthalmic knives.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tecfen Medical directly.
Affected Products
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
Quantity: 26 units
Why Was This Recalled?
Sterility assurance for Ophthalmic knives.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tecfen Medical
Tecfen Medical has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report